FDA product code JGC: Tryptophan Measurement (Colorimetric), Globulin
JGC is the FDA product code for tryptophan measurement (colorimetric), globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel. Devices under JGC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tryptophan Measurement (Colorimetric), Globulin |
| Device class | Class I |
| Regulation | 21 CFR 862.1330 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JGC devices
openFDA lists no recalls for product code JGC.
Frequently asked questions
What is FDA product code JGC?
JGC is the FDA product code for tryptophan measurement (colorimetric), globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel.
What device class is JGC?
Class I, regulation 21 CFR 862.1330. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JGC
- Run a recall and safety report across every JGC manufacturer
- Watch product code JGC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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